Nurse-led Primary Healthcare Intervention Model in Women's Health Management in Hong Kong (JCDATAZONEWH)

The University of Hong Kong (HKU)

Status

Enrolling

Conditions

Osteoporosis

Hypertension

Breast Cancer

Vasomotor Symptoms

Cervical Cancers

Anxiety

Urinary Incontinence

Colorectal Cancer

Depression - Major Depressive Disorder

Treatments

Behavioral: Minimal Intervention

Behavioral: Nurse-Led Risk-Based 5As Primary Healthcare Model

Study type

Interventional

Funder types

Other

Identifiers

NCT06628388

UW 24-501

Details and patient eligibility

About

The goal of this randomized clinical trial is to learn if a nurse-led primary healthcare intervention can help improve health management in women adults aged 45 to 64, and to develop an evidence-based primary healthcare model for women. The questions it aims to answer are:

if the intervention improves medical resource use, especially at 3-month from the beginning of intervention? if the intervention improves health confidence, self-management, and quality-of-life? if the intervention improves health conditions as reflected by risk levels?

Researchers will compare the intervention with the control group over time to see if there are better medical resource use, health confidence, self-management, and quality-of-life, and health conditions risk levels.

All participants will be asked to answer a set of questionnaires assessing their social demographics, health-related status, and risk levels of the targeted health conditions. All participants will receive an education booklet containing essential knowledge and available medical resources. Participants in the intervention group will receive nurse-led 5As (ask, advice, assess, assist, arrange) intervention which offers risk-specific health services. Participants will be followed at 3-, 6-, 12-month; with high risk participants will be followed additionally at 1-month after the beginning of intervention. Participants in the waitlist control group will be given general health advice as minimal intervention, followed-up at 3- and 6-month, provided with intervention of the same content with intervention group at 6-month, followed-up at 7-month and 12-month.

Full description

Background:

Globally, the aging population is on the rise, leading to the phenomenon known as the "feminization of aging" (United Nations, 2017). In most regions, women outlive men and face an increased risk of severe illnesses and multiple health conditions, significantly impacting their quality of life (Chłoń-Domińczak et al., 2014). In Hong Kong, the Family Health Service of the Department of Health provides the Woman Health Services including health assessment, health education, and individual counseling at three Woman Health Centres (WHCs) to women aged at or below 64 years, and its coverage is very limited. Hence, there is a lack of evidence-based services in primary healthcare settings such as DHCs for identifying and stratifying health risks among women and effective interventions in promoting women's health, particularly for those older female adults.

Nurse-led intervention is an intervention where nurses play central roles and have autonomous rights in decision-making as well as authority in customizing patient care (Li et al., 2020). Despite the important role of nurses in primary health care, this is no innovative nurse-led intervention model targeting women's health in Hong Kong.

The '5As model', which was initially developed for smoking cessation based on changes to different stages within the healthcare intervention (Wang et al., 2019), consists of five main steps: identifying health status and behavior for each individual (Ask), advising and urging the behavioral changes (Advice), assessing the willingness and readiness to change (Assess), providing supports and referrals to individuals willing to change (Assist), and scheduling follow-ups to address barriers and discuss personal progress (Arrange). It has been found to be an effective and simple model for nurses to deliver healthcare promotion and education intervention in community (Kolac et al., 2023; Slev et al., 2020). Brief intervention model as such would be much more feasible in PHC settings (Saitz et al., 2010).

As women reach the middle stage of their life between the ages of 45 and 64, a significant number of them undergo hormonal changes linked to the transitions through menopause. These changes often lead to the emergence of novel health challenges (Nasreen et al., 2021). Apart from the commonly observed age-related risk of developing colorectal cancer, more prevalent conditions affecting women in this life phase are vasomotor symptoms (VMS), urinary incontinence (UI), depression and anxiety, osteoporosis, breast cancer, hypertension, and cervical cancer. Hence, based on the 5As model, a nurse-led risk-based primary healthcare intervention is proposed for women's health management in Hong Kong.

Study Design:

A stepped-wedge cluster randomized waitlist-controlled trial (SWT) will be conducted. The study period will consist of four consecutive phases with each lasting for four months. The three social service organizations will be the three clusters to be randomized. In the first phase, all participants in all three clusters will be allocated to the waitlist-control treatment. In the second phase, newly joined participants in cluster 1, randomly determined, will be exposed to the intervention condition, while the other two clusters remain in the waitlist-control. In the third phase, newly joined participants in cluster 1 and 2, will be allocated to the intervention condition, while cluster 3 remain receiving the waitlist-control condition. In the fourth phase, all newly recruited participants in the three clusters will be allocated to intervention condition. At 6-month follow-up, the waitlist-control participants will be given the same treatment as in intervention condition. A web-based portal system will be created for nurses to facilitate better case management and client coordination.

Procedures:

The NGO staff will receive two day training on clinical knowledge, health condition specific advice and appropriate community medical resources, behavioral modification skills, and study workflow. Booster training the study flow, risk assessment, and use of the web-based portal system will be provided during transition period. Service units of the three non-governmental organizations (NGOs) in the three districts (Aberdeen Kai Fong Association in Southern District (AKA), Haven of Hope Christian Services in Sai Kung District (HOHCS), and Hong Kong Sheng Kung Hui Welfare Council Limited in Wong Tai Sin District (SKHWC)) will screen and recruit appropriate participants for this trial. Recruitment ads will be posted onto offline (e.g., on-site posters) and online platforms (e.g., Facebook and Instagram). Women aged between 45 and 64 will be continuously recruited in the 4 recruitment phases. Participants would include but not limited to those who that are regular attendees (e.g., members) of the three social service organizations, and those in the general population who are seeking primary healthcare services through various offline/online recruitment approaches. Participants will undergo eligibility screening following registration. Eligible participants with consents will be enrolled in the current stepped-wedge waitlist-control randomized trial. For participants who do not meet the eligibility criteria for the current trial but express their willingness in receiving primary healthcare services, such rights will be protected and healthcare services/resources in need will be provided.

Enrollment

1,728 estimated patients

Sex

Female

Ages

45 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Hong Kong female residents aged 45 to 64 years old; and
Able to read and communicate in Chinese (either Cantonese or Mandarin).

Exclusion criteria

Have a terminal illness (e.g., advanced cancer, dementia, pulmonary, neurological, motor-neuron, and advanced cardiovascular disease), or with a life expectancy of less than six months;
Diagnosed with psychiatric or psychological disorders (e.g., panic disorder, psychosis);
Currently taking medication(s) or receiving treatment(s) for psychiatric and psychological disorders;
Pregnant or in lactation period, or have plans for pregnancy within 1 year; or
Have moderate or severe cognitive impairment.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

1,728 participants in 2 patient groups

Minimal intervention

Active Comparator group

Description:

Participants allocated to the control group condition will be given minimal intervention in standard practices at baseline and 3-month. It consist of general health education and advice, where the health information is open resources available for the public. No risk-stratified services nor active referral will be conducted by nurse until 6-month assessment is completed. After that, they will immediately receive intervention based on their 6-month assessment, and booster interventions at 7-month contact and 12-month follow-up.

Treatment:

Behavioral: Minimal Intervention

Nurse-led Risk-based 5As Intervention Arm

Experimental group

Description:

Participants allocated to the intervention condition will receive the nurse-led 5As model intervention at baseline, 1- and 3-month boosters, and 6- and 12-month follow-ups. The current model includes risk assessments and stratification, general health education booklet, consultations and active referrals based on personal risk stratification at baseline and 3-month booster, with additional booster session at 1-month, and follow-up sessions at 6- and 12-month from baseline. For participants with high risk of any target health conditions at baseline and 3-month booster, medical referral and service utilization (e.g., GPs/network doctors/specialist consultation at health centres/hospitals/clinics, screening, therapies, corresponding District Health Centre schemes, etc.) will be arranged at the visits. Such medical resource utilization among participants will be encouraged and motivated at 1-month booster session.

Treatment:

Behavioral: Nurse-Led Risk-Based 5As Primary Healthcare Model